Trial · NCT03197376
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | All subjects who received all primary series doses of study vaccines, had post-dose immunogenicity measurement(s) with no major protocol deviations | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | 4 weeks after the third dose | Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit \>-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit \>0.5. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit \>-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit \>0.5. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus) | 4 weeks after the third dose | Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.For each Ag in the pentavalent, RV, OPV vaccines, non-inferiority shown if 2-sided 95% CI for difference in response proportions (PNEUMOSIL-Synflorix) had lower limit \>-0.10. For this, pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Anti-pertussis Toxoid GMCs for the Pertussis Antigen | 4 weeks after the third dose | Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.Non-inferiority was defined as 2-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit\>0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae).For this analysis, pooled PNUEMOSIL data used as specified in SAP | IU/mL | GEOMETRIC_MEAN |
| PRIMARY | Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | 4 weeks after the third dose | Evaluated in a subset of subjects who received all primary series doses, had postdose immunogenicity results with no major protocol deviations. Non-inferiority was defined as a two-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit \> 0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae). | U/mL | GEOMETRIC_MEAN |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | 7 days (including day of vaccination) | Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | 7 days (including day of vaccination) | Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | 7 days (including day of vaccination) | Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | 7 days (including day of vaccination) | Reported in a subset of subjects who got 3 doses and booster dose of the study vaccine and had post-vaccination safety data.Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used (specified in SAP) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | 4 weeks post last vaccination | Evaluated in all subjects who received a study vaccination and provided some post-vaccination safety data. Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of All SAEs by Severity and Relatedness | 4 weeks post last vaccination | Evaluated in all subjects who received a study vaccination and provided some post-vaccination safety data. Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | 4 weeks after the third dose | For 6A and 19A serotypes, proportions with IgG concentration ≥ 0.35 µg/mL were compared using a z-test for proportions.Test was done at the 2-sided 2.5% significance level to adjust for superiority test. Analysis was done on pooled PNEUMOSIL data as specified in SAP | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | For 6A and 19A serotypes, GMCs were compared by a two-sample t-test on the difference.Test was done at the 2-sided 2.5% significance level to adjust for superiority test.The 95% CIs around treatment-group responses, and 97.5% CIs for treatment-group differences in response were reported.Analysis was done on pooled PNEUMOSIL data as specified in SAP | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number and Percentage of Subjects With Functional Antibody Responses | 4 weeks after the third dose | In a subset of subjects who got 3 primary doses of study vaccines, had postdose immunogenicity measurement and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes in PNEUMOSIL, i.e., OPA seroresponse rate (titer≥1:8) differences.Pooled PNEUMOSIL data was used as noted in the SAP | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serotype-specific OPA Geometric Mean Titer | 4 weeks after the third dose | In a subset of subjects who got 3 primary doses of study vaccines, had postdose immunogenicity measurement and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes in PNEUMOSIL, i.e., ratio of OPA GMTs (and corresponding 95% CIs).Pooled PNEUMOSIL data was used as noted in the SAP | titer | GEOMETRIC_MEAN |
| SECONDARY | Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurement \& no major PDs, comparisons based on ratios of IgG GMC post booster to IgG GMC post primary series. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), \& corresponding 95% CIs. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | In a subset of subjects who got 3 primary series and a booster dose of study vaccines, had postdose immunogenicity measurement(s) with no major protocol deviations, serotype-specific GMC of IgG Antibody and treatment group ratios of IgG GMCs (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurement \& no major PDs, comparisons based on ratios of OPA GMT post booster to OPA GMT post primary series. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), \& corresponding 95% CIs. | titer | GEOMETRIC_MEAN |
| SECONDARY | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | In a subset of subjects who got 3 primary series and a booster dose of study vaccines, had postdose immunogenicity measurement(s) with no major protocol deviations, serotype-specific OPA GMT and treatment group ratios of OPA GMT (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP | titer | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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